CINXE.COM

<!DOCTYPE html><html lang="en" class="h-100"><head><meta charset="utf-8"><meta http-equiv="X-UA-Compatible" content="IE=edge"><meta name="viewport" content="width=device-width, initial-scale=1, shrink-to-fit=no"><title> UCSF Acute Lymphoblastic Leukemia Trial → Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma</title><meta property="og:title" content="UCSF Acute Lymphoblastic Leukemia Trial: Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma"><meta name="description" content="This Acute Lymphoblastic Leukemia and Leukemia study at UCSF ends March 2026."><meta property="og:description" content="This Acute Lymphoblastic Leukemia and Leukemia study at UCSF ends March 2026."><meta property="og:url" content="https://clinicaltrials.ucsf.edu/trial/NCT02625480"><link rel="canonical" href="https://clinicaltrials.ucsf.edu/trial/NCT02625480"><meta name="author" content="UCSF"><meta name="generator" content="edu.ucsf.ctsi.rt.trialfinder"><meta name="referrer" content="origin-when-cross-origin"><meta name="google-site-verification" content="JXe923j97sTSgp-6yxsCdd25Muv0wMNfDR27ba3ER8M"><meta name="msvalidate.01" content="4E5209CC6688B86BBDD2FE074176C029"><link rel="shortcut icon" href="https://clinicaltrials.ucsf.edu/assets/local/ucsf/img/favicon.png"><link rel="alternate" type="application/atom+xml" title="UCSF Clinical Trials" href="https://clinicaltrials.ucsf.edu/meta/feed.atom"><meta property="og:type" content="website"><meta name="twitter:card" content="summary"><meta name="twitter:site" content="@ucsf"><meta property="og:image" content="https://clinicaltrials.ucsf.edu/assets/local/ucsf/img/share-image.jpg"><link rel="stylesheet" href="https://clinicaltrials.ucsf.edu/assets/local/ucsf/ucsf_identity/banners.css"> <link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/bootstrap@4.4.1/dist/css/bootstrap.min.css" integrity="sha256-L/W5Wfqfa0sdBNIKN9cG6QA5F2qx4qICmU2VgLruv9Y=" crossorigin="anonymous"><link rel="stylesheet" href="https://cdn.jsdelivr.net/gh/coliff/bootstrap-rfs@4.3.1/bootstrap-rfs.css" media="screen and (max-width: 1200px)" integrity="sha256-DgOE2c1ekD0TaTyiCQuH2NdeiZ6VifYJdLdfDwq6C+U=" crossorigin="anonymous"><link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/animate.css@3.7.2/animate.min.css" integrity="sha256-PHcOkPmOshsMBC+vtJdVr5Mwb7r0LkSVJPlPrp/IMpU=" crossorigin="anonymous"><link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/font-awesome@4.7.0/css/font-awesome.min.css" integrity="sha256-eZrrJcwDc/3uDhsdt61sL2oOBY362qM3lon1gyExkL0=" crossorigin="anonymous"><link rel="stylesheet" href="https://clinicaltrials.ucsf.edu/assets/css/style.css"><link rel="stylesheet" href="https://clinicaltrials.ucsf.edu/assets/local/ucsf/css/style-local.css"> <script src="https://polyfill-fastly.io/v3/polyfill.min.js?features=default%2CObject.assign%2CObject.entries%2CPromise%2CURLSearchParams%2CURL" crossorigin="anonymous" defer></script> <script src="https://cdn.jsdelivr.net/jquery/2.2.4/jquery.min.js" integrity="sha256-BbhdlvQf/xTY9gja0Dq3HiwQF8LaCRTXxZKRutelT44=" crossorigin="anonymous" defer></script><script src="https://cdn.jsdelivr.net/npm/bootstrap@4.4.1/dist/js/bootstrap.bundle.min.js" integrity="sha256-OUFW7hFO0/r5aEGTQOz9F/aXQOt+TwqI1Z4fbVvww04=" crossorigin="anonymous" defer></script><script src="https://cdn.jsdelivr.net/npm/readmore-js@2.2.1/readmore.min.js" integrity="sha256-ygz7RPJkJA9GMkV/1XKiK5GEfenXOdkEj2yhi8LRipU=" crossorigin="anonymous" defer></script> <script src="https://clinicaltrials.ucsf.edu/assets/js/app.js" defer></script><script>var google_analytics_live_mode=0;var google_analytics_id='UA-1142388-28';var google_analytics_hostname='clinicaltrials.ucsf.edu';if(google_analytics_id&&google_analytics_hostname&&window.location&&window.location.hostname&&window.location.hostname===google_analytics_hostname){google_analytics_live_mode=1}var google_analytics_js_url='https://www.google-analytics.com/analytics_debug.js';if(google_analytics_live_mode){google_analytics_js_url='https://www.google-analytics.com/analytics.js'}(function(c,h,e,b,f,a,d){c['GoogleAnalyticsObject']=f;c[f]=c[f]||function(){(c[f].q=c[f].q||[]).push(arguments)},c[f].l=1*new Date();a=h.createElement(e),d=h.getElementsByTagName(e)[0];a.async=1;a.src=b;d.parentNode.insertBefore(a,d)})(window,document,'script',google_analytics_js_url,'ga');if(!google_analytics_live_mode){}if(google_analytics_live_mode){ga('create',google_analytics_id,'auto')}else{ga('set','sendHitTask',null)}ga('require','outboundLinkTracker');ga('require','pageVisibilityTracker');ga('send','pageview');var s_opt={};s_opt['s_apid']='53G5XLK75T';s_opt['s_ixnm']='trials_ucsf';s_opt['s_ixky']='6e038166fd15da69c2ed075975c00816';s_opt['s_plac']=undefined;s_opt['s_mlti']=false;var _paq=window._paq=window._paq||[];_paq.push(['setTrackerUrl','https://clinicaltrials.ucsf.edu/action/t/l/']);_paq.push(['setSiteId','9']);_paq.push(['setCustomDimension',1,'trial\u002dpage']);_paq.push(['trackPageView']);_paq.push(['enableLinkTracking']);_paq.push(['enableHeartBeatTimer']);(function(){var a=document,g=a.createElement('script'),s=a.getElementsByTagName('script')[0];g.type='text/javascript';g.async=true;g.src='https://clinicaltrials.ucsf.edu/action/t/js/';s.parentNode.insertBefore(g,s)})();</script><script async src="https://cdn.jsdelivr.net/npm/autotrack@1.0.3/autotrack.js" integrity="sha256-MFv0PQKCj7HPlACiJTgQ+3rHnOSY1a510jcQGGwtemQ=" crossorigin="anonymous"></script><script type="application/ld+json"> { "@context": "https://schema.org/", "@type": "WebSite", "publisher": { "@type": "MedicalOrganization", "name": "UCSF", "address": "San Francisco Bay Area", "url": "https://www.ucsf.edu/", "logo": "https://s2.googleusercontent.com/s2/favicons?domain_url=https%3A%2F%2Fwww.ucsf.edu%2F", "sameAs": [ "https://twitter.com/@ucsf" ] } } </script><meta name="ahrefs-site-verification" content="5f73483e1fea16c76799e8797bf1b843c1c0cda17921ee5e1670f98bd81223f4"></head><body class="trial-page bg-light d-flex flex-column"> <a id="skip-to-main-content" class="sr-only sr-only-focusable" href="#content">Skip to main content</a> <header id="header" class="mb-4"><div id="ucsf-banner-nav"><div class="container-fluid"><div class="top-header-container" style="max-width: 100%"><div><ul class="menu"><li class="first"><a href="https://www.ucsf.edu">University of California San Francisco</a></li><li><a href="https://www.ucsfhealth.org/">UCSF Medical Center</a></li><li><a href="https://www.ucsf.edu/search">Search UCSF</a></li><li><a href="https://www.ucsf.edu/about">About UCSF</a></li></ul></div></div></div></div><nav class="navbar navbar-expand-md navbar-light d-print"> <a class="navbar-brand" href="https://clinicaltrials.ucsf.edu/"> <img src="https://clinicaltrials.ucsf.edu/assets/local/ucsf/img/site-name.png" alt="UCSF Clinical Trials"> </a> <button class="navbar-toggler" type="button" data-toggle="collapse" data-target="#navbar--menu--primary-content" aria-controls="navbar--menu--primary-content" aria-expanded="false" aria-label="Toggle navigation"> <span class="navbar-toggler-icon"></span> </button> <div class="collapse navbar-collapse justify-content-end" id="navbar--menu--primary-content"><ul class="navbar-nav"> <li class="nav-item" id="navbar--menu--home"> <a class="nav-link" href="https://clinicaltrials.ucsf.edu/">Search</a> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="https://clinicaltrials.ucsf.edu/browse/" id="navbar--menu--browse-dropdown-link" role="button" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false"> Browse </a> <div class="dropdown-menu dropdown-menu-right" aria-labelledby="navbar--menu--browse-dropdown-link"> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/">All trials</a> <div class="dropdown-divider"></div><div class="dropdown-header">Trials for…</div> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/healthy">Healthy volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/pediatric" title="Pediatric clinical trials, for people under age 18">People under 18</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/geriatric" title="Geriatric clinical trials, for people over age 65">People over 65</a> <div class="dropdown-divider"></div><div class="dropdown-header">Trials seeking…</div> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/black" title="Trials that may be particularly relevant to Black volunteers"> Black volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/chinese" title="Trials that may be particularly relevant to Chinese volunteers"> Chinese volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/hmong" title="Trials that may be particularly relevant to Hmong volunteers"> Hmong volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/korean" title="Trials that may be particularly relevant to Korean volunteers"> Korean volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/latinx" title="Trials that may be particularly relevant to Latinx volunteers"> Latinx volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/lgbtqia" title="Trials that may be particularly relevant to LGBTQIA+ volunteers"> LGBTQIA+ volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/mena" title="Trials that may be particularly relevant to Middle Eastern or North African volunteers"> Middle Eastern or North African volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/native-hawaiian" title="Trials that may be particularly relevant to Native Hawaiian volunteers"> Native Hawaiian volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/south-asian" title="Trials that may be particularly relevant to South Asian volunteers"> South Asian volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/veteran" title="Trials that may be particularly relevant to Veteran volunteers"> Veteran volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/vietnamese" title="Trials that may be particularly relevant to Vietnamese volunteers"> Vietnamese volunteers</a> </div></li> <li class="nav-item" id="navbar--menu--equity" data-nosnippet> <a class="nav-link" href="https://clinicaltrials.ucsf.edu/about/equity">Equity <span class="d-none d-xl-inline">in Research</span></a></a> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="https://clinicaltrials.ucsf.edu/about/" id="navbar--menu--about-dropdown-link" role="button" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false"> About <span class="d-none d-lg-inline">the site</span> </a> <div class="dropdown-menu dropdown-menu-right" aria-labelledby="navbar--menu--about-dropdown-link"> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/">About UCSF Clinical Trials</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/for-researchers">For Researchers</a> <div class="dropdown-divider"></div><div class="dropdown-header">Learn more in…</div> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/chinese" data-nosnippet>Chinese</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/spanish" data-nosnippet>Spanish</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/vietnamese" data-nosnippet>Vietnamese</a> </div></li></ul></div> </nav><nav class="breadcrumb-and-search-bar navbar navbar-expand navbar-light d-print d-flex justify-content-between"> <div><ol class="breadcrumb navbar-text my-0 pl-1" itemscope="itemscope" itemtype="https://schema.org/BreadcrumbList"><li itemprop="itemListElement" itemscope itemtype="https://schema.org/ListItem"> <a href="https://clinicaltrials.ucsf.edu/" itemscope="itemscope" itemprop="item" itemtype="https://schema.org/Thing" id="navbar--breadcrumb--link-1"> Home <meta itemprop="name" content="UCSF Clinical Trials"> </a> <meta itemprop="position" content="1"></li><li itemprop="itemListElement" itemscope itemtype="https://schema.org/ListItem"> <a href="https://clinicaltrials.ucsf.edu/acute-lymphoblastic-leukemia" itemscope="itemscope" itemprop="item" itemtype="https://schema.org/Thing" aria-description="See all trials related to Acute Lymphoblastic Leukemia" id="navbar--breadcrumb--link-2"> <span itemprop="name">Acute Lymphoblastic Leukemia</span> Studies </a> <meta itemprop="position" content="2"></li><li class="active">This trial</li></ol><script type="application/ld+json"> { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "item": { "@id": "https://clinicaltrials.ucsf.edu/", "name": "UCSF Clinical Trials" } },{ "@type": "ListItem", "position": 2, "item": { "@id": "https://clinicaltrials.ucsf.edu/acute-lymphoblastic-leukemia", "name": "Acute Lymphoblastic Leukemia" } }] } </script><script type="application/ld+json"> { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "item": { "@id": "https://clinicaltrials.ucsf.edu/", "name": "UCSF Clinical Trials" } },{ "@type": "ListItem", "position": 2, "item": { "@id": "https://clinicaltrials.ucsf.edu/leukemia", "name": "Leukemia" } }] } </script><script type="application/ld+json"> { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "item": { "@id": "https://clinicaltrials.ucsf.edu/", "name": "UCSF Clinical Trials" } },{ "@type": "ListItem", "position": 2, "item": { "@id": "https://clinicaltrials.ucsf.edu/lymphoma", "name": "Lymphoma" } }] } </script><script type="application/ld+json"> { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "item": { "@id": "https://clinicaltrials.ucsf.edu/", "name": "UCSF Clinical Trials" } },{ "@type": "ListItem", "position": 2, "item": { "@id": "https://clinicaltrials.ucsf.edu/non-hodgkin-lymphoma", "name": "Non-Hodgkin Lymphoma" } }] } </script></div> <div><div class="d-none d-md-block navbar-text"><form method="GET" action="https://clinicaltrials.ucsf.edu/" class="form-inline my-1" role="search"> <label class="sr-only" for="header-search--input">Search</label> <input id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><div class="h3 alert alert-danger text-center">This study is in progress, not accepting new patients</div><h1 id="summary--title"> Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../acute-lymphoblastic-leukemia">Acute Lymphoblastic Leukemia</a></span><span class="comma-list-item"> <a href="../leukemia">Leukemia</a></span><span class="comma-list-item"> <a href="../lymphoma">Lymphoma</a></span><span class="comma-list-item"> <a href="../non-hodgkin-lymphoma">Non-Hodgkin Lymphoma</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages up to 21 years</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2016-02-01">February 2016</time></span></div><div> completion around <time datetime="2026-03-31">March 2026</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2015-12-09"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/michelle.hermiston" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Michelle Hermiston</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=175871" alt="Headshot of Michelle Hermiston" loading="lazy"><figcaption class="figure-caption">Michelle Hermiston</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor <a href="../acute-lymphoblastic-leukemia" class="trial--link-to-condition-in-text">acute lymphoblastic leukemia</a> (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).</p><p>As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell <a href="../non-hodgkin-lymphoma" class="trial--link-to-condition-in-text">Non Hodgkin Lymphoma</a> (NHL).</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>All participants who received KTE-X19, and have completed at least 24 months of protocol assessments, will be transitioned to a separate long-term follow-up (LTFU) study. The purpose of the LTFU study (KT-US-982-5968.) is to complete the remainder of the 15-year follow-up assessments.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> Relapsed/Refractory B-precursor <a href="../acute-lymphoblastic-leukemia" class="trial--link-to-condition-in-text">Acute Lymphoblastic Leukemia</a></span>, <span> Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma</span>, <span> Lymphoma</span>, <span> Leukemia</span>, <span> Non-Hodgkin Lymphoma</span>, <span> Precursor Cell Lymphoblastic Leukemia-Lymphoma</span>, <span> Lymphoid Leukemia</span>, <span> B-Cell Lymphoma</span>, <span> Cyclophosphamide</span>, <span> Fludarabine</span>, <span> Brexucabtagene autoleucel</span>, <span> Brexucabtagene Autoleucel (KTE-X19)</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages up to 21 years</strong></p><p>for the ALL Cohort</p><ul><li>Relapsed or refractory B-precursor ALL defined as one of the following: <ul><li> Primary refractory disease</li><li> Any relapse within 18 months after first diagnosis</li><li> Relapsed or refractory disease after 2 or more lines of systemic therapy</li><li> Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from stem cell transplant at the time of enrollment</li></ul></li><li>Disease burden defined as at least 1 of the following: <ul><li> Morphological disease in the bone marrow (> 5% blasts)</li><li> Minimal/Measurable Residual Disease (MRD) positive (threshold 10^-4 by flow or Polymerase chain reaction (PCR))</li></ul></li><li>Individuals with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs</li><li>Age ≤ 21 years and weight ≥ 6 kg at the time of assent or consent per Institutional Review Board (IRB) guidelines</li><li>Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening</li><li>Adequate renal, hepatic, pulmonary and cardiac function defined as: <ul><li> Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ≥ 60 mL/min</li><li> Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN)</li><li> Total bilirubin ≤ 1.5 x ULN, except in individuals with Gilbert's syndrome</li><li> Left ventricular shortening fraction (LVSF) ≥ 30% or <a href="../left-ventricular-ejection-fraction" class="trial--link-to-condition-in-text">left ventricular ejection fraction</a> (LVEF) ≥ 50%, as determined by an echocardiogram or multi-gated acquisition scan (MUGA), no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO) and no clinically significant <a href="../cardiac-arrhythmia" class="trial--link-to-condition-in-text">arrhythmias</a></li><li> No clinically significant pleural effusion, pericardial effusion or <a href="../peritoneal-effusion" class="trial--link-to-condition-in-text">ascites</a></li><li> Baseline oxygen saturation > 92% on room air</li></ul></li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><p>for the ALL Cohort</p><ul><li>Diagnosis of Burkitt's leukemia/lymphoma according to the World Health Organization (WHO) classification or <a href="../chronic-myeloid-leukemia" class="trial--link-to-condition-in-text">chronic myelogenous leukemia</a> lymphoid blast crisis</li><li>History of malignancy other than non-melanoma <a href="../skin-cancer-melanoma" class="trial--link-to-condition-in-text">skin cancer</a> or <a href="../carcinoma-in-situ" class="trial--link-to-condition-in-text">carcinoma in situ</a> (e.g. cervix, bladder, breast) unless disease free for at least 3 years</li><li>History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study</li><li>Central nervous system (CNS) involvement and abnormalities: <ul><li> Any <a href="../central-nervous-system-tumor" class="trial--link-to-condition-in-text">CNS tumor</a> mass by imaging and/or parameningeal mass (cranial and/or spinal)</li><li> Presence of central nervous system (CNS)-3 disease, defined as white blood cell (WBC) ≥ 5/µL in Cerebrospinal Fluid (CSF) with presence of lymphoblasts with or without neurologic symptoms</li><li> CNS-2 disease, defined as WBC < 5/µL in CSF with presence of lymphoblasts and with neurologic symptoms (see note below for further clarification).</li><li> Note: Neurologic symptoms may include but are not limited to cranial nerve palsy (if not explained by extracranial tumor) and clinical cord compression.</li><li> (Individuals with CNS-1 (no detectable lymphoblasts in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study)</li><li> History or presence of CNS disorder, such as cerebrovascular ischemia/hemorrhage, <a href="../dementia" class="trial--link-to-condition-in-text">dementia</a>, cerebellar disease, or any <a href="../autoimmune-disease" class="trial--link-to-condition-in-text">autoimmune disease</a> with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects not related to lymphoma by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment. Individuals with <a href="../seizure" class="trial--link-to-condition-in-text">seizure disorders</a> requiring active anticonvulsive medication.</li></ul></li><li>History of concomitant genetic syndrome such as <a href="../anemia" class="trial--link-to-condition-in-text">Fanconi anemia</a>, Kostmann syndrome, Shwachman-Diamond syndrome or any other known <a href="../bone-disease" class="trial--link-to-condition-in-text">bone marrow failure syndrome</a></li><li>History of <a href="../heart-attack" class="trial--link-to-condition-in-text">myocardial infarction</a>, cardiac angioplasty or stenting, unstable angina, or other clinically significant <a href="../heart-disease" class="trial--link-to-condition-in-text">cardiac disease</a> within 12 months of enrollment</li><li>History of symptomatic <a href="../deep-vein-thrombosis" class="trial--link-to-condition-in-text">deep vein thrombosis</a> or <a href="../pulmonary-embolism" class="trial--link-to-condition-in-text">pulmonary embolism</a> within 6 months of enrollment.</li><li>Primary immunodeficiency</li><li>History of human immunodeficiency virus (HIV) infection or acute / chronic active <a href="../hepatitis-b" class="trial--link-to-condition-in-text">hepatitis B</a> or C infection. Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines.</li><li>Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.</li><li>Prior medication: <ul><li> Prior CD19 directed therapy (other than blinatumomab), including CAR+ T cell, bispecific T cell engager (BiTE), and antibody drug conjugate (ADC), with the exception of individuals who received brexucabtagene autoleucel (KTE-X19) in this study and are eligible for re-treatment</li><li> Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis</li><li> Donor lymphocyte infusion (DLI) within 28 days prior to enrollment</li><li> Any drug used for graft-versus-host disease (GVHD) within 4 weeks prior to enrollment</li></ul></li><li>Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment</li><li>Live vaccine ≤ 6 weeks prior to enrollment</li><li>Women of child-bearing potential who are pregnant or <a href="../breastfeeding" class="trial--link-to-condition-in-text">breastfeeding</a> because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization are not considered to be of childbearing potential</li><li>Individuals of both genders of child-bearing potential who are not willing to use a birth control method considered to be highly effective per protocol from the time of consent through 6 months after conditioning chemotherapy or brexucabtagene autoleucel (KTE-X19) infusion, whichever is longer.</li></ul><p>Key Inclusion Criteria for the NHL Cohort</p><ul><li>Histologically confirmed aggressive B cell NHL</li><li>Relapsed or refractory histologically confirmed aggressive B-cell NHL per 1 or more of the following: <ul><li> Primary refractory disease</li><li> Any relapse within 18 months after first diagnosis</li><li> Relapsed or refractory disease after 1 or more lines of systemic therapy</li><li> Relapsed or refractory disease after autologous /allogeneic stem cell transplant provided individual is at least 6 weeks from autologous stem cell transplant and at least 3 months from allogeneic stem cell transplant at the time of enrollment</li></ul></li><li>Individuals must have received adequate prior therapy including at a minimum all of the following: <ul><li> Anti-CD20 <a href="../monoclonal-antibody" class="trial--link-to-condition-in-text">monoclonal antibody</a>, unless the investigator determines that the tumor is CD20 negative</li><li> An anthracycline-containing chemotherapy regimen</li></ul></li><li>Age <18 years old and weight ≥ 6kg</li><li>Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening</li><li>Adequate renal, hepatic, pulmonary, and cardiac function defined as the following: <ul><li> Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ≥ 60 mL/min</li><li> Serum ALT/AST ≤ 5 ULN</li><li> Total bilirubin ≤1.5 x ULN except in individuals with Gilbert's syndrome</li><li> Left ventricular shortening fraction(LVSF) ≥ 30% or <a href="../left-ventricular-ejection-fraction" class="trial--link-to-condition-in-text">left ventricular ejection fraction</a> (LVEF) ≥ 50%, as determined by ECHO or MUGA, no evidence of pericardial effusion (except trace or physiological) as determined by an ECHO, and no clinically significant <a href="../cardiac-arrhythmia" class="trial--link-to-condition-in-text">arrhythmias</a></li><li> Baseline oxygen saturation > 92% on room air</li></ul></li></ul><p>Key Exclusion Criteria for the NHL Cohort</p><ul><li>History of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, breast), or follicular lymphoma (FL) unless disease free for at least 3 years</li><li>Autologous stem cell transplant within <6 weeks of planned KTE-X19 infusion; allogeneic stem cell transplant within <3 months of planned KTE-X19 infusion</li><li>Prior CD19 targeted therapy other than blinatumomab and loncastuximab tesirine-lpyl</li><li>History of severe, immediate hypersensitivity reaction attributed to aminoglycosides</li><li>Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.</li><li>History of <a href="../hiv-aids" class="trial--link-to-condition-in-text">HIV infection</a> or acute/chronic active hepatitis B or C infection. Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines</li><li>Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by International Bone Marrow Transplant Registry (IBMTR) index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment.</li><li>CNS involvement and abnormalities: <ul><li> Any CNS tumor mass and/or parameningeal mass (cranial and/or spinal) by imaging with current or prior history of neurological symptoms within 3 months prior to screening.</li></ul></li></ul><p>Note: CNS involvement without neurologic symptoms will be allowed.</p><ul><li>History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment. Individuals with seizure disorders requiring active anti-convulsive medication. <ul><li> History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment</li><li> Primary immunodeficiency</li><li> History of severe immediate hypersensitivity reaction to any of the agents used in this study</li><li> Live vaccine ≤ 6 weeks prior to planned start of lymphodepleting chemotherapy regimen</li><li> Individuals of both genders of child-bearing potential who are not willing to use a birth control considered to be highly effective per protocol from the time of consent through 12 months after the completion of lymphodepleting chemotherapy or brexucabtagene autoleucel (KTE-X19) infusion, whichever is longer.</li><li> Prior medication:</li></ul></li><li>Prior CD19 directed therapy (other than blinatumomab), including CAR+ T cell, BiTE, and ADC, with the exception of individuals who received brexucabtagene autoleucel (KTE-X19) in this study and are eligible for re-treatment</li><li>Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis</li><li>DLI within 28 days prior to enrollment</li><li>Any drug used for GVHD within 4 weeks prior to enrollment</li></ul><p>Note: Other protocol defined Inclusion/Exclusion criteria may apply.</p></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF Benioff Children's Hospital</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94158</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Children's Hospital Los Angeles</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Los Angeles</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 90027</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/michelle.hermiston" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Michelle Hermiston</a> </strong> </span><br> Professor Emeritus, Pediatrics, School of Medicine. Authored (or co-authored) 153 research publications </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> in progress, not accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2016-02-01">February 2016</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2026-03-31">March 2026</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Kite, A Gilead Company</dd><dt class="col-sm-3 text-sm-right">Links</dt><dd class="col-sm-9"> <a href="https://www.gileadclinicaltrials.com/study/?id=KTE-C19-104" class="trial--link-to-external-study-link d-block" target="_blank" rel="noopener ugc nofollow"><i class="fa fa-link" aria-hidden="true"></i> Gilead Clinical Trials Website</a> </dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT02625480" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT02625480</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 1/2 research study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">About 95 people participating</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-10-24">October 24, 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block d-print-none" id="secondary-column"> <div id="sidebar"></div> </div></div> </div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)","code":{"@type":"MedicalCode","codeValue":"NCT02625480","codingSystem":"ClinicalTrials.gov"},"description":"The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL). As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell Non Hodgkin Lymphoma (NHL).","healthCondition":[{"@type":"MedicalCondition","name":"Acute Lymphoblastic Leukemia"},{"@type":"MedicalCondition","name":"Leukemia"},{"@type":"MedicalCondition","name":"Lymphoma"},{"@type":"MedicalCondition","name":"Non-Hodgkin Lymphoma"}],"name":"Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma","sameAs":"https://clinicaltrials.gov/study/NCT02625480","sponsor":[{"@type":"Organization","name":"Kite, A Gilead Company"},{"@context":"https://schema.org/","@type":"Person","affiliation":{"@type":"Organization","name":"UCSF"},"description":"Professor Emeritus, Pediatrics, School of Medicine. Authored (or co-authored) 153 research publications","image":"https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=175871","isicV4":"7210","jobTitle":"Principal Investigator","name":"Michelle Hermiston","url":"https://profiles.ucsf.edu/michelle.hermiston"}],"status":"https://schema.org/ActiveNotRecruiting","studyLocation":[{"@type":"AdministrativeArea","address":{"@type":"PostalAddress","addressCountry":"United States","addressLocality":"San Francisco","addressRegion":"California","postalCode":"94158"},"name":"UCSF Benioff Children's Hospital"}],"studySubject":[{"@type":"MedicalEntity","name":"Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia"},{"@type":"MedicalEntity","name":"Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma"},{"@type":"MedicalEntity","name":"Lymphoma"},{"@type":"MedicalEntity","name":"Leukemia"},{"@type":"MedicalEntity","name":"Non-Hodgkin Lymphoma"},{"@type":"MedicalEntity","name":"Precursor Cell Lymphoblastic Leukemia-Lymphoma"},{"@type":"MedicalEntity","name":"Lymphoid Leukemia"},{"@type":"MedicalEntity","name":"B-Cell Lymphoma"},{"@type":"MedicalEntity","name":"Cyclophosphamide"},{"@type":"MedicalEntity","name":"Fludarabine"},{"@type":"MedicalEntity","name":"Brexucabtagene autoleucel"},{"@type":"MedicalEntity","name":"Brexucabtagene Autoleucel (KTE-X19)"}],"trialDesign":["https://schema.org/MultiCenterTrial"]},{"@type":"Offer","availabilityEnds":"2026-03-31","availabilityStarts":"2016-02-01","hasAdultConsideration":[],"name":"Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma","price":0,"priceCurrency":"USD","sku":"NCT02625480","validFrom":"2016-02-01","validThrough":"2026-03-31"},{"@context":"https://schema.org/","@type":"Place","address":{"@type":"PostalAddress","addressCountry":"United States","addressLocality":"San Francisco","addressRegion":"California","postalCode":"94158"},"name":"UCSF Benioff Children's Hospital"},{"@context":"https://schema.org/","@type":"Person","affiliation":{"@type":"Organization","name":"UCSF"},"description":"Professor Emeritus, Pediatrics, School of Medicine. Authored (or co-authored) 153 research publications","image":"https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=175871","isicV4":"7210","jobTitle":"Principal Investigator","name":"Michelle Hermiston","url":"https://profiles.ucsf.edu/michelle.hermiston"}] </script> </main><footer class="mt-auto" role="contentinfo" data-nosnippet><div id="ucsf--footer--body"><div class="container" data-nosnippet><div class="row mb-1 d-print-none"><div class="col-12 text-center text-md-left"> We use cookies to operate our website, analyze performance, and improve your experience on our site. <a href="https://www.ucsf.edu/website-privacy-policy" target="_blank">Learn more.</a> </div></div><div class="row"><div class="col-md-6 text-center text-md-left"><p class="my-0"> © The Regents of the University of California </p></div><div class="col-md-6 text-center text-md-right pt-3 pt-md-0"> <a href="https://websites.ucsf.edu/digital-accessibility" target="_blank">Accessibility</a> <a href="https://www.ucsf.edu/website-privacy-policy" target="_blank">Privacy Policy</a> <a href="https://websites.ucsf.edu/website-terms-use" target="_blank">Terms of Use</a> </div></div></div></div></footer><script>(function(){var b=document.createElement('script');b.type='text/javascript';b.async=true;b.src='//siteimproveanalytics.com/js/siteanalyze_8343.js';var a=document.getElementsByTagName('script')[0];a.parentNode.insertBefore(b,a)})();</script></body></html>